If your device has successfully passed proof-of-concept and pre-clinical testing, you are ready to move on to the next round, industrial production. But this transition should not be underestimated. Design transfer expert Anne Mouret teaches us the best practices in moving from R&D to production
When you get to the final stage of the product development lifecycle and your prototype provides clinically relevant outcomes, it’s time to start thinking about manufacturing. You will now have the option to either sell your prototype to an established company that will take over its production and pay you royalties once the device goes to market, or you can develop the device yourself. If you decide on the latter, you must be financially prepared for the costs of production. Normally, startups do not tend to spend a lot of money on R&D specifically for this reason.
The process of taking a device from prototype to manufacturing is called design transfer and is done under the supervision of a design transfer engineer. He or she will have to ensure that the device’s design documentation, selection of components and production methods are clearly defined, as these will provide the basis on which the device will be manufactured. These requirements are particularly relevant if the manufacturing is outsourced to an original equipment manufacturer (OEM) rather than done in-house.
Anne Mouret is an experienced design transfer engineer, having successfully coordinated the manufacture of medical devices for both startups and established companies. She coordinated the industrialisation of a single-use laparoscopic retractor developed by French startup Surgical Perspective, before moving to the design transfer department of a global medtech company last year. She shares with us the lessons she learned while working at both ends of the spectrum.
‘Once you have all the product specifications in place, including user requirements, and you have written down the manufacturing instructions, it’s time to build the initial production units. The idea of design transfer is to build units that are not prototypes but that are produced as they would be during manufacturing. After ensuring that these Initial Production Units correspond to your production specifications, then it’s time for manufacturing,’ Mouret says.
So what is more viable for a startup to do in terms of product manufacturing – outsource it or do it in-house? Although you might be set on saving money by producing in-house, you might not be equipped enough to produce at industrial level, Mouret explains.
‘Small companies should consider contract manufacturers because as a startup, your core competency is product development, so you won’t have the resources or manpower necessary to manufacture yourself,’ she says.
‘Even established companies usually subcontract the hardware assembly of a device, and choose to do only the valuable steps of the manufacturing process themselves, like customising and calibrating the device.’
Whether the production is being managed by a design transfer expert in a startup, or the supplier quality department in bigger companies, they must always ensure an honest relationship with the subcontractor, based on upfront discussions on both parties’ expectations and capabilities.
As long as both parties are clear about the deliverables, they usually tend to see eye to eye on the manufacturing procedures. But conflicts can occur, Mouret admits. ‘Things can get tricky when you choose to perform the validation via the subcontractor, instead of doing it internally. This usually occurs with startups, so it’s imperative for them to understand that subcontractors may have their own quality system and weaker validation requirements than they might expect. That is why this aspect should always be discussed at the beginning of the manufacturing process, to make sure all parties are aligned,’ Mouret explains.
Things can also get tricky if you choose to do your design transfer too soon. Startups are usually rushed by lack of funding at this stage, so it can be a challenge for them to find the right balance between performing the proper transfer with minimal funds in a limited time frame. But don’t proceed to production if your product design is not yet frozen, Mouret says, as you will risk repeating the transfer if your design proves faulty.
‘This can be difficult at times because you have to show the equivalence between the different versions of the design and that the transfer addresses the last production specifications available, which are compliant with the last version of the device,’ she explains.
But even big companies struggle with delayed product development and unmet delivery goals, which can be detrimental to the design transfer, according to Mouret. But the pressure of time and money is naturally more serious for startups. The advantage of a big company is that it can be more meticulous and rigorous in the transfer but, on the other hand, a small company can advance more quickly as the requirements for the transfer are not as thorough and time-consuming.
Don’t be fooled into thinking design transfer ends once production is underway, however. While your design might be frozen, it may occur that some components become obsolete subsequently and you have to go back to the drawing board and find new ones to then take into R&D. Other times, when the product is already out on the market, you might receive consumer complaints that could cause your product to be redesigned. Whatever the case, attention must be paid constantly to what impact your device is making on the end user.
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